HeartBeam Completes $25 Million Capital Raise and Updates 2023 Strategic Focus and Financial Guidance
May 03 2023 - 7:31AM
Business Wire
HeartBeam to Focus on Becoming the Global
Leader in Ambulatory Vectorcardiography, the Highest Resolution ECG
Monitoring Platform
Funding to Enable Company to Execute on
Upcoming Clinical, Regulatory and Commercial Milestones, Extends
Cash Runway into Late 2024
HeartBeam to Host Conference Call to Discuss
Financing, Strategic Initiatives and First Quarter 2023 Financial
Results on Thursday May 11, 2023 at 4:30 p.m. ET
HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology
company that has developed the first and only 3D-vector
electrocardiogram (VECG) platform to help physicians detect heart
attacks anytime, anywhere as well as diagnose other common heart
conditions today announced closing of its secondary offering of
16,666,666 shares of HeartBeam’s common stock. This financing will
allow HeartBeam to fund its upcoming clinical and regulatory
milestones related to its HeartBeam AIMIGo™ system and prepare for
commercialization in 2024.
HeartBeam received net proceeds of $23.2 million from the
offering, after deducting the placement agent discounts and
commissions and offering expenses.
Public Ventures LLC acted as placement agent for the
offering.
HeartBeam has adjusted its strategic focus to enable timely
delivery of its breakthrough ambulatory VECG products, the
Company’s key future value drivers, as follows:
- Immediately focus on obtaining an FDA 510(k) clearance for the
HeartBeam AIMIGo credit card- sized VECG device, followed by a
second 510(k) clearance on the system’s ability to synthesize an
electrocardiogram (ECG). The goal of this second FDA clearance is
to demonstrate that HeartBeam’s synthesized 12-lead ECG is
equivalent to standard recorded 12-lead ECGs. These clearances
provide a key value creation path, as they will enable physicians
to remotely monitor patients and immediately interpret any
concerning cardiac events.
- Demonstrate through clinical trials in 2023 the performance of
the HeartBeam AIMIGo platform, which we believe is the most
advanced ambulatory cardiac detection platform available. HeartBeam
believes this will drive clinical and patient adoption.
- Shift the commercial launch until obtaining the 510(k)
clearance for 12-lead equivalence. The company plans to submit this
application to the FDA in late 2023 and pursue initial
commercialization in 2024.
- Undertake an aggressive pre-commercial effort to define initial
market segments and identify potential business partners.
- Continue aggressive development of its intellectual property
through our partnership with PatentVest, a unified technology
development and patent law firm focused on creating IP leadership
for development stage technology companies. The partnership is
clearly focused on the goal of creating clear leadership in the
area of ambulatory VECG cardiac detection.
- Add world leading Key Opinion Leaders (KOLs) to our Medical
Advisory Board to help guide our clinical and regulatory
development. These Advisory Board members will be announced in the
near future.
As a result of these strategic goals, we are updating our
financial guidance and expect no material commercial revenue for
2023.
“We are extremely pleased to have received this additional
funding, which will allow us to achieve our important upcoming
milestones and extends our cash runway into late 2024,” said
Branislav Vajdic, Ph.D. HeartBeam Founder and CEO. “We are also
excited to be working with Public Ventures, which is an outstanding
strategic partner with a long track record of helping companies
grow and realize their full potential. The strategic focus we are
announcing today are important steps for us to demonstrate the
value of our novel VECG technology and to achieve the clinical and
regulatory milestones to bring these important products into the
hands of physicians and patients.”
Christopher Marlett, Co-Founder and CEO of Public Ventures,
added, “HeartBeam has the potential to positively impact the lives
of millions of people, to change the standard of care, and to be
the leader in the emerging area of ambulatory VECG. We are pleased
to be supporting the Company as it executes on this vision, and we
believe that it has the plan in place to achieve its goals.”
HeartBeam will hold a conference call to discuss the financing
and the strategic initiatives, along with our first quarter 2023
financial results, on Thursday May 11, 2023 at 4:30 p.m. ET.
To access the call, please use the following information:
Date:
Thursday May 11, 2023
Time:
4:30 p.m. Eastern time (1:30 p.m. Pacific
time)
Dial-in:
1-844-826-3035
International Dial-in:
1-412-317-5195
Conference Code:
10178249
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1611445&tp_key=13a316a5f0
A telephone replay will be available approximately two hours
after the call and will run through August 11, 2023, by dialing
1-844-512-2921 from the U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 10178249. The replay can
also be viewed through the webcast link above and the presentation
utilized during the call will be available in the company’s
investor relations section here.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company
that has developed the first and only 3D-vector ECG platform for
heart attack detection anytime, anywhere. By applying a suite of
proprietary algorithms to simplify vector electrocardiography
(VECG), the HeartBeam platform enables patients and their
clinicians to determine if symptoms are due to a heart attack,
quickly and easily, so care can be expedited, if required.
HeartBeam has two patented products in development. HeartBeam AIMI™
is software for acute care settings that provides a 3D comparison
of baseline and symptomatic 12-lead ECG to more accurately identify
a heart attack. HeartBeam AIMIGo™ is the first and only credit
card-sized 12-lead output ECG device coupled with a smart phone app
and cloud-based diagnostic software system to facilitate remote
heart attack detection. HeartBeam AIMI and HeartBeam AIMIGo have
not yet been cleared by the US Food and Drug Administration (FDA)
for marketing in the USA or other geographies. For more
information, visit HeartBeam.com.
Forward-Looking Statements
All statements in this release that are not based on historical
fact are "forward-looking statements." While management has based
any forward-looking statements included in this release on its
current expectations, the information on which such expectations
were based may change. Forward-looking statements involve inherent
risks and uncertainties which could cause actual results to differ
materially from those in the forward-looking statements, as a
result of various factors including those risks and uncertainties
described in the Risk Factors and in Management’s Discussion and
Analysis of Financial Condition and Results of Operations sections
of our in our Forms 10-K, 10-Q and other reports filed with the SEC
and available at www.sec.gov. We urge you to consider those risks
and uncertainties in evaluating our forward-looking statements. We
caution readers not to place undue reliance upon any such
forward-looking statements, which speak only as of the date made.
Except as otherwise required by the federal securities laws, we
disclaim any obligation or undertaking to publicly release any
updates or revisions to any forward-looking statement contained
herein (or elsewhere) to reflect any change in our expectations
with regard thereto or any change in events, conditions or
circumstances on which any such statement is based.
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version on businesswire.com: https://www.businesswire.com/news/home/20230503005321/en/
Investor Relations Contact: Chris Tyson Executive Vice
President MZ North America Direct: 949-491-8235 BEAT@mzgroup.us
www.mzgroup.us
Media Contact: media@heartbeam.com
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